Director leading vendor outsourcing strategy and governance for Ergomed’s clinical trials and pharmaceutical clients. Driving vendor selection, partnerships, compliance, and scalable trial delivery across North America.
About the role
- Associate Medical Director ensuring oncology trial medical and safety integrity. Supporting biopharmaceutical clients through medical monitoring, regulatory review, and clinical study oversight.
Responsibilities
- Provide independent medical monitoring support for assigned clinical studies, respond to medical inquiries, assist with protocol interpretation and medical review of data to ensure protocol adherence, consistency and scientific validity of the data
- Assist the project manager in client discussions regarding safety-related questions or concerns
- Prepare medical monitoring plans and other relevant plans for assigned studies prior to study start
- Review serious adverse events, SUSARs, safety reports and analyze similar cases
- Support the clinical data management team with MedDRA and WHO drug coding
- Review clinical study documents, including protocols, informed consent forms, clinical study reports and safety reports
- Contribute to the setup and conduct of data safety monitoring boards and dose-escalation meetings
- Participate in and present at study startup meetings, investigator meetings and other relevant meetings
- Provide 24/7 on-call medical support for urgent medical issues
- Train project teams on medical and therapeutic aspects of trials
- Review protocol deviations
- Identify study-related risks and contribute to the risk management plan
- Review medical deliverables and contribute to budget tracking
- Participate in therapeutic and drug development conferences, with potential presentations
- Maintain effective communication and client relationships
- Participate in client assessments, site visits and proposal presentations
Requirements
- Medical degree (MD)
- Experience as an oncologist
- Minimum of three years of relevant professional experience with strong expertise in oncology
- Good knowledge of GxP standards
- In good standing with local, provincial and national regulatory and licensing authorities and certifying bodies
- Understanding of GDPR/HIPAA, CFR/CTR/CTD and applicable local regulatory requirements
- Excellent written and verbal communication skills, including strong command of English
- Presentable, outgoing and client-focused
- Ability to work in the dynamic, fast-paced environment of a growing company
- Strong administrative skills
- Proficient in Word, Excel and PowerPoint
Benefits
- Comprehensive benefits package according to location
- Competitive salary based on location
- Departmental training and education budget to support professional development
- Flexible working hours (within reason)
- Remote or hybrid work options depending on location
- Opportunities for leadership roles and mentorship
- Participation in our buddy program, available to new hires and existing employees
- Internal mobility and career advancement opportunities
- Employee referral program with financial incentives
- Access to online training for soft and technical skills via ADP and our internal platforms
- Eligibility for our spot bonus program, rewarding exceptional project contributions
- Eligibility for our long-service recognition program, acknowledging loyalty and commitment of long-tenured employees
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